PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC
Form 483 issued March 17, 2021 · Guayama, Puerto Rico
- Inspection
- Mar 1 – Mar 17, 2021
- Investigators
- Jose Velez· Miguel A. Martinez
- Observations
- 5
- Pages
- 14
- FEI number
- 3007343300
In short: On March 17, 2021, FDA issued a Form 483 with 5 observations to PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC in Guayama, Puerto Rico (FEI 3007343300) after an inspection that ran Mar 1 – Mar 17, 2021. The investigators were Jose Velez and Miguel A. Martinez. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
This inspection in context
Jose Velez
24 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmPF Consumer Healthcare B.V. (Puerto Rico Operations) LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC?
FDA listed 5 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC?
Jose Velez and Miguel A. Martinez are named on this Form 483, for the inspection of Mar 1 – Mar 17, 2021. Each investigator has a profile showing what they cite most.
When was PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC inspected by FDA?
The inspection ran Mar 1 – Mar 17, 2021, and the Form 483 is dated March 17, 2021.
How do I get the full Form 483 for PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.